RecruitingNot Applicable

Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting

United States500 participantsStarted 2026-03-11

Plain-language summary

The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (\>6 hours of life).

Who can participate

Age range

32 Weeks – 41 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Both of the following: * Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated * Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization. Exclusion Criteria: Any one of the following: * Neonates with known or suspected congenital anomalies * Neonates for whom only comfort measures are planned or possible at time of delivery * Neonates whose parents actively declined the Minnesota Research Authorization. * Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.

Timeframe: 1 years

Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome

Timeframe: 2 years

Trial details

NCT IDNCT07344714

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-31

Contact for this trial

Lavonne M. Liedl, LRT

507-255-1828 liedl.lavonne@mayo.edu

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Newborn trials

Who can participate

Age range

32 Weeks – 41 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.